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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Angioplasty, Peripheral, Transluminal
510(k) Number K915895
Device Name STEALTH DILATION CATHETER SYSTEM (MODIFIED)
Applicant
TARGET THERAPEUTICS
130 RIO ROBLES
P.O. BOX 610458
SAN JOSE,  CA  95134
Applicant Contact THERESA NAZAROFF
Correspondent
TARGET THERAPEUTICS
130 RIO ROBLES
P.O. BOX 610458
SAN JOSE,  CA  95134
Correspondent Contact THERESA NAZAROFF
Regulation Number870.1250
Classification Product Code
LIT  
Date Received07/17/1991
Decision Date 06/04/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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